FDA Issues Emergency Use Authorization for Generic Over-the-Counter Drug to Treat New World Screwworm in Dogs and Cats
The FDA issued an Emergency Use Authorization for generic nitenpyram tablets to treat New World screwworm infestations in dogs and cats weighing at least two pounds and aged at least four weeks.
Manufacturers of generic nitenpyram, veterinary professionals, and regulatory affairs teams managing emergency use products for companion animals.
The issuance of an EUA for a generic veterinary drug indicates an urgent public health or animal health need regarding New World screwworm. This suggests a shift in the regulatory status of nitenpyram for this specific indication, allowing for expedited availability. Regulatory teams should note that this authorization is limited to specific age and weight cohorts, requiring precise adherence to the EUA conditions to maintain compliance.
Regulatory and supply chain teams responsible for nitenpyram distribution should review the specific EUA requirements for labeling and distribution. QA departments should ensure that generic tablets used for this indication meet the weight and age requirements specified in the authorization.
FDA today issued an Emergency Use Authorization (EUA) for generic Nitenpyram Tablets (nitenpyram) for the treatment of New World screwworm (NWS) infestations (myiasis) in dogs, puppies, cats, and kittens that weigh at least two pounds and are at least four weeks old.
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